Refractive ErrorsNCT06021353
Contralateral Study of WaveLight® Femtosecond Laser Devices for Corneal Flap Creation
A study testing UV fs-Laser, IR fs-Laser and LASIK in people with Refractive Errors, run by Alcon Research at 1 site in Australia.
Trial summary
The purpose of this study is to assess the WaveLight Ultraviolet Femtosecond Laser System, Model 1026 (UV fs-Laser) corneal flap creation accuracy as compared to the already marketed WaveLight FS200 Infrared Femtosecond Laser, Model 1025 (IR fs-Laser). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractive Errors
- What is being tested?
- UV fs-Laser, IR fs-Laser and LASIK
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteAustralia
- Study dates
- 20 Oct 2023to 12 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Good ocular health;
- Natural lens with no evidence of cataract;
- Eligible for LASIK;
- Stable refraction;
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Presence of dry eye;
- Contraindicated systemic disease or ocular conditions;
- Treatment with a contraindicated medication;
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contralateral Study of the WaveLight® Ultraviolet Femtosecond Laser, Model 1026 Versus the WaveLight® FS200 Infrared Femtosecond Laser, Model 1025 for Corneal Flap Creation
The purpose of this study is to assess the WaveLight Ultraviolet Femtosecond Laser System, Model 1026 (UV fs-Laser) corneal flap creation accuracy as compared to the already marketed WaveLight FS200 Infrared Femtosecond Laser, Model 1025 (IR fs-Laser).
Read the detailed description
Subjects who qualify to participate will have both eyes treated in the study (one eye with the UV fs-Laser and the other eye with the IR fs-Laser) and will attend a total of 5 study visits over a period of approximately 2 months. This study will be conducted outside the United States.
- Conditions
- Refractive Errors
- Being tested
- UV fs-Laser, IR fs-Laser, LASIK
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UV fs-LaserDevice
Also called WaveLight Ultraviolet Femtosecond Laser Model 1026 with Patient Interface Model 1507
Stationary scanning spot femtosecond laser used for corneal flap creation during refractive surgery
IR fs-LaserDevice
Also called WaveLight FS200 Infrared Femtosecond Laser Model 1025 with Patient Interface Model 1515
Stationary scanning spot femtosecond laser used for corneal flap creation during refractive surgery
LASIKProcedure or surgery
Laser-assisted in situ keratomileusis (LASIK) surgery
| Study group | Role | What they receive |
|---|---|---|
| UV fs-Laser | Other | First surgical eye randomly assigned to the UV fs-Laser with the second surgical eye (fellow eye) assigned to the IR fs-Laser for the purpose of corneal flap creation during LASIK surgery Receives: Device: UV fs-Laser; Procedure: LASIK |
| IR fs-Laser | Other | First surgical eye randomly assigned to the IR fs-Laser with the second surgical eye (fellow eye) assigned to the UV fs-Laser for the purpose of corneal flap creation during LASIK surgery Receives: Device: IR fs-Laser; Procedure: LASIK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum deviation of corneal flap thickness at the margins from achieved central flap thickness at 1 month
Corneal flap thickness will be measured using optical coherence tomography (OCT)
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start20 Oct 2023
- Primary completion12 Dec 2024
- Study completion12 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive ErrorsStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Principal Clinical Trial Lead, CRD Surgical, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021353
- Sponsor's protocol ID
- RFO268-E005
- Status last verified
- Dec 2024
- First submitted
- 28 Aug 2023
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contralateral Study of the WaveLight® Ultraviolet Femtosecond Laser, Model 1026 Versus the WaveLight® FS200 Infrared Femtosecond Laser, Model 1025 for Corneal Flap Creation
- ClinicalTrials.gov ID
- NCT06021353
- Acronym / sponsor ID
- RFO268-E005
- Conditions
- Refractive Errors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 1 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the WaveLight Ultraviolet Femtosecond Laser System, Model 1026 (UV fs-Laser) corneal flap creation accuracy as compared to the already marketed WaveLight FS200 Infrared Femtosecond Laser, Model 1025 (IR fs-Laser).
Detailed description
Subjects who qualify to participate will have both eyes treated in the study (one eye with the UV fs-Laser and the other eye with the IR fs-Laser) and will attend a total of 5 study visits over a period of approximately 2 months. This study will be conducted outside the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UV fs-Laser | Other | Device: UV fs-Laser, Procedure: LASIKFirst surgical eye randomly assigned to the UV fs-Laser with the second surgical eye (fellow eye) assigned to the IR fs-Laser for the purpose of corneal flap creation during LASIK surgery |
| IR fs-Laser | Other | Device: IR fs-Laser, Procedure: LASIKFirst surgical eye randomly assigned to the IR fs-Laser with the second surgical eye (fellow eye) assigned to the UV fs-Laser for the purpose of corneal flap creation during LASIK surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Good ocular health;
- Natural lens with no evidence of cataract;
- Eligible for LASIK;
- Stable refraction;
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (4 listed)
- Presence of dry eye;
- Contraindicated systemic disease or ocular conditions;
- Treatment with a contraindicated medication;
- Other protocol-defined exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UV fs-LaserAlso: WaveLight Ultraviolet Femtosecond Laser Model 1026 with Patient Interface Model 1507Stationary scanning spot femtosecond laser used for corneal flap creation during refractive surgery | Device | UV fs-Laser |
| IR fs-LaserAlso: WaveLight FS200 Infrared Femtosecond Laser Model 1025 with Patient Interface Model 1515Stationary scanning spot femtosecond laser used for corneal flap creation during refractive surgery | Device | IR fs-Laser |
| LASIKLaser-assisted in situ keratomileusis (LASIK) surgery | Procedure or surgery | IR fs-Laser, UV fs-Laser |
Primary outcome
Maximum deviation of corneal flap thickness at the margins from achieved central flap thickness at 1 month
Time frame: Month 1
Corneal flap thickness will be measured using optical coherence tomography (OCT)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Principal Clinical Trial Lead, CRD Surgical study director
Alcon Research, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UV fs-Laser, IR fs-Laser and LASIK in people with Refractive Errors, run by Alcon Research at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum deviation of corneal flap thickness at the margins from achieved central flap thickness at 1 month (time frame: Month 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.